Kornimate/medical-research-clean huggingface dataset:
evaluation of the discontinuation of maintenance corticosteroid treatment in quiescent systemic lupus

Conditions: Systemic Lupus Erythematosus

Summary: systemic lupus (sle) is a chronic disease for which long term treatments are warranted. the aim of this study was to study the possibility of corticosteroids interruption in patients with quiescent sle treated since at least one year with 5 milligrams of predonisone per day.


Eligibility criteria:
inclusion criteria: * patients with sle according to the acr revised criteria. * quiescent disease without flare since at least one year (selena sledai \< or equal to 4, bilag c, d or e, pga 0) _ treatment with 5 milligrams/day of prednisone since at least 1 year exclusion criteria: * failure to sign the informed consent or unable to consent * patient participating to another clinical trial * pregnancy or plan to become pregnant

Keywords: systemic lupus erythematosus corticosteroids chronic disease
immune profiling after hdr in local relapsed prostate cancer

Conditions: Prostate Cancer; PD-L1

Summary: immunotherapy is currently revolutionizing the field in oncology. however, prostate cancer until now fails to respond to classical io, like pd-1 and ctla-4 inhibitors. radiotherapy (rt) delivered to the primary tumor impacts both tumor cells and surrounding stromal cells. radiation damage to cancer cells exposes tumor-specific antigens leading to increased visibility to the immune system by improved priming and activation of cytotoxic t cells. rt-induced modulation of the tumor microenvironment may also facilitate the recruitment and infiltration of immune cells by increasing the expression or t-cell attracting chemokines and by increasing t-cell docking molecules on the endothelial cells like vcam-1. the main-hypothesis is that hdr-brachytherapy will turn an immunologically "cold" (no t-cell infiltrations) prostate cancer into an immunologically "hot" (cd4 and cd8-cell infiltrations) tumor, creating leverage points for different forms of io.

prospective analysis of biopsies from 10 patients with local recurrence in the prostate selected for salvage hdr brachytherapy in maastro clinic, maastricht. hdr treatment is standard in maastro clinic for local relapses of prostate cancer after previously irradiation (internal or external). biopsies will be taken at 4 different time points (before and after the 1st fraction; before the 2nd and 3rd fraction of the salvage treatment). several immunotyping (expression of pd-(l)-1, cxcl12, il-23 receptor, etc.) and hla class i expression will be performed on the biopsies. in addition, hla genotypes will be determined on dna isolated from pheripheral blood. the plasma and the biopsies will be stored for eventually additional research.

Eligibility criteria:
inclusion criteria: * local relapse of prostate cancer, who is candidate for a salvage hdr treatment: * biochemical relapse (psa increase) * local relapse on imaging: psma scan, mp-mri * pathology proven relapse * willing and able to comply with the study prescriptions. * 18 years or older * before patient registration, written informed consent must be given according to ich/gcp, and national/local regulations. exclusion criteria: * not eligible for proposed (hdr brachytherapy) treatment: * life expectancy \< 10 years * distant metastasis * recently turp with big urethral defect * not able to stop anticoagulants * flow \< 10 ml/sec • no compliance to study procedure
trial to evaluate the safety and immunogenicity of 3 lots of 20-valent pneumococcal conjugate vaccine in pneumococcal vaccine-naïve adults

Conditions: Pneumococcal Disease

Summary: this is a phase 3, randomized, double-blind study with a 4-arm parallel design. adults 18 through 49 years of age with no history of pneumococcal vaccination will be randomized in a 2:2:2:1 ratio to receive a single dose of: 20vpnc lot 1; 20vpnc lot 2; 20vpnc lot 3; or 13vpnc.


Eligibility criteria:
inclusion criteria: 1. male or female adults ≥18 and \<50 years of age. 2. adults determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study, including adults with preexisting stable disease, defined as disease not requiring significant change in therapy in the previous 6 weeks or hospitalization for worsening disease within 12 weeks before receipt of investigational product. 3. female subject of childbearing potential or male subject who is able to father children, and willing to use a highly effective method of contraception as outlined in this protocol for at least 28 days after the dose of investigational product; or female subject not of childbearing potential or male subject not able to father children. exclusion criteria: 1. previous vaccination with any licensed or investigational pneumococcal vaccine, or planned receipt through study participation. 2. serious chronic disorder including metastatic malignancy, severe chronic obstructive pulmonary disease (copd) requiring supplemental oxygen, end-stage renal disease with or without dialysis, clinically unstable cardiac disease, or any other disorder that, in the investigator's opinion, excludes the subject from participating in the study. 3. history of microbiologically proven invasive disease caused by s pneumoniae. 4. pregnant female subjects or breastfeeding female subjects (known or suspected).
characterization of disease related changes in inflammatory bowel disease using fecal metabolite profiling

Conditions: Inflammatory Bowel Diseases

Summary: the purpose of the study is to evaluate fecal metabolites profiles of inflammatory bowel disease(ibd) patients versus healthy controls (hc).


Eligibility criteria:
inclusion criteria: * clinical diagnosis of ibd * age \>18 years exclusion criteria: * use of antibiotics in the preceding month * intake of pre- or probiotics
acupuncture in the treatment of depression

Conditions: Depressive Disorders; Depression

Summary: the current large randomized placebo-controlled trial is testing the ability of acupuncture to treat major depression. the study is unique in that treatment effects will be from the perspective of both western psychiatry and chinese medicine.

depression is an unfortunately common condition for which people often seek alternative (non-western) treatments, perhaps because conventional treatments do not consistently provide lasting relief. a pilot study (allen, schnyer and hitt, 1998) suggests that acupuncture, a popular but under-researched alternative treatment derived from chinese medicine, holds sufficient promise as a treatment for depression to warrant a larger-scale clinical trial. the investigators propose to conduct a larger-scale test of the efficacy of acupuncture in this trial. because relapse and recurrence of major depression are quite common, the investigators also will assess the clinical status of participants for 18 months after treatment concludes. in the first phase of this double-blind randomized clinical trial, 150 men and women meeting criteria for major depression will be randomly assigned to a treatment approach or to a waitlist control. all participants will ultimately receive acupuncture designed to address their own particular constellation of depressive symptoms. at the end of this first phase, blind assessments will be used to compare treatment effects from the perspectives of both western psychiatry and chinese medicine. after this treatment phase, participants will be assessed several times over the next 18 months. the study is designed to evaluate the efficacy and clinical significance of acupuncture as a treatment for major depression, and to examine the convergence of western-based and chinese-medicine-based outcome measures. finally, the study will determine whether changes in energetic pattern mediate changes in western defined depression severity, and explore whether patient and history variables predict responses to acupuncture treatments.

Eligibility criteria:
inclusion criteria: * must meet criteria for major depression. * must be free of other mental or physical disorders that could cause depression, and also free from conditions that would typically exclude participants from trials involving pharmacologic antidepressants. * cannot be receiving other treatments or require immediate clinical attention.
pilot evaluation of the empower neuromodulation system in aud patients

Conditions: Alcohol Use Disorder

Summary: this study evaluates the effects of peripheral nerve stimulation on alcohol craving and consumption in participants with alcohol use disorder (aud). this is a pilot investigation in which all participants will receive the active treatment.

alcohol use disorder (aud) is a major public health concern, affecting over 16 million americans. peripheral nerve stimulation via acupuncture has been shown to directly decrease alcohol craving and self-administration. theranova has developed the empower neuromodulation system, a non-invasive, portable transcutaneous electrical nerve stimulation (tens) device intended to stimulate peripheral nerves for the treatment of aud. in this study, we will conduct a cross-over, home-use study in participants with aud. participants will have a one-week control period with no treatment followed by two weeks of twice daily treatment with the empower device. we will evaluate endpoints for safety and effectiveness.

Eligibility criteria:
inclusion criteria: * is male or female ≥ 21 year of age at visit 1 * has a current diagnosis of alcohol use disorder per dsm-5 by clinician assessment * endorses criterion 4 in dsm-5 * has a desire to maintain abstinence or, if not abstinent, a desire to reduce or quit alcohol use * has a breath alcohol concentration of 0.00% at enrollment * is able to provide informed consent * is able to understand spoken and written english * is capable and willing to follow all study-related procedures exclusion criteria: * has been diagnosed with unstable psychosis, epilepsy, peripheral neuropathy, or nerve damage * requires acute medical detoxification from alcohol based on a score of 12 or more on the clinical institute withdrawal assessment of alcohol scale (ciwa-ad) * has implanted electrical and/or neurostimulator device (e.g. pacemaker, defibrillator, vagal neurostimulator, deep brain stimulator, spinal stimulator, sacral stimulator, bone growth stimulator, or cochlear implant) * has an electrically conductive metal object (e.g. jewelry) that cannot be removed from the palm and will directly contact the gel electrodes of the empower neuromodulation system * will not, for the duration of the participation in the study, have a living situation that provides regular access to an electrical outlet. * is pregnant, breastfeeding, or unwilling to practice birth control during participation in the study * has used an investigational drug/device therapy within the past 4 weeks * is deemed unsuitable for enrollment in the study by the pi
safety study of tritanrix-hepb/hib-menac, tritanrix-hepb/hiberix, and mencevax acwy vaccines in children

Conditions: Whole Cell Pertussis; Tetanus; Hepatitis B; Diphtheria; Haemophilus Influenzae Type b; Diphtheria-Tetanus-Pertussis-Hepatitis B-Haemophilus Influenzae Type b-Neisseria Meningitidis Vaccin

Summary: this study will be conducted in two stages. in the diphtheria, tetanus, pertussis (dtp) booster phase, subjects will receive a booster dose of tritanrix-hepb/hib-menac or tritanrix-hepb/hiberix (active control) at 15 to 18 or 24 months in a single-blind manner so that the subjects' parents will not know which vaccine was administered to their child. in the mencevax acwy phase at 24-30 months, a dose of mencevax acwy will be given in an open manner to only those subjects who received less than 4 doses of tritanrix-hepb/hib-menac. no blood samples will be taken in this safety study.

subjects previously primed with tritanrix-hepb/hib-menac will receive tritanrix-hepb/hib-menac or tritanrix-hepb/hiberix vaccine (at 15-18/24 m), respectively, without or with mencevax acwy vaccine at 24 to 30 months of age. subjects previously primed with tritanrix-hepb/hiberix will receive tritanrix-hepb/hib-menac or tritanrix-hepb/hiberix vaccine (at 15-18/24 m) with mencevax acwy vaccine at 24 to 30 months of age.

Eligibility criteria:
inclusion criteria: * written informed consent obtained from the parent or guardian of a healthy male or female child between, and including 15 and 18 months age (philippines)/ 15 and 24 months age (thailand) at the time of vaccination and who have previously received a 3-dose primary vaccination in the studies dtpwhb/hibmenac-tt-004 (cpms no. 759346/004) or dtpw-hbv=hib-menac-tt-013 (etrack no. 100791). exclusion criteria: * use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the vaccination, or planned use during the study period. * chronic administration (\> than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to vaccination. * planned administration/administration of a vaccine not foreseen by the study protocol within 30 days of vaccination. note: oral poliovirus vaccine can be given concomitantly. * booster vaccination against diphtheria, tetanus, pertussis, hepatitis b, haemophilus influenzae type b (hib) and/or meningococcal serogroups a and c disease, after the date of the study conclusion visit of the primary vaccination study.

Keywords: hib & neisseria meningitidis serogroups a & c diseases
relationship between serum interleukin-20 level and paclitaxel-associated neuropathy

Conditions: Neuropathy Associated With Dysproteinaemias

Summary: this study aims to investigate the correlation between paclitaxel-induced neuropathy and the measurement values of serum il-20 levels at baseline and during chemotherapy in patients who will receive neoadjuvant or adjuvant paclitaxel chemotherapy with the diagnosis of early-stage or locally advanced breast cancer

* patients with the diagnosis of breast cancer who will be started on adjuvant or neoadjuvant paclitaxel chemotherapy will be included in the study. * patients who will receive standard breast cancer treatment (4 cycles of cyclophosphamide 600mg/m2 every 21 days + epirubicin 90mg/m2 followed by weekly paclitaxel 80 mg/m2 x 12 sessions) will be included in the study. * age, gender, additional disease, diagnosis dates, previous diseases and breast cancer subtypes of the patients who signed the informed consent form will be obtained from the electronic information system or by asking face-to-face. * serum il-20 level will be studied from blood tests taken for routine chemotherapy. no extra blood sample will be taken for the study * neuropathy assessment will be evaluated with organisation for research and treatment of cancer (eortc) chemotherapy-induced peripheral neuropathy (qlq-cipn20) questionnaire, the sensitivity, and specificity of which have previously been demonstrated for chemotherapy-induced neuropathy. the turkish validation questionnaire of the study, which was made before, will be conducted by the physician in charge before the paclitaxel chemotherapy and at the 1st and 12th weeks after the treatment, by asking the patient face to face. * patients with diabetes mellitus and patients who had a history of peripheral neuropathy will be excluded from the study.

Eligibility criteria:
inclusion criteria: * patients receiving paclitaxel chemotherapy for local advanced or early-stage breast cancer * \>18 years exclusion criteria: * advanced stage breast cancer * having before peripheral neuropathy * patients with diabetes mellitus * \< 18 years

Keywords: paclitaxel peripheral neuropathy peripheral neuropathy induced by paclitaxel
rtms for the prevention treatment of cm: a single arm study

Conditions: Chronic Migraine

Summary: we design this pilot, single arm study to explore the safety and efficacy of repetitive transcranial magnetic stimulation (rtms) for the treatment of chronic migraine. the hypothetical control group is pooled sham group in latest meta-analysis. we expect a significant improvement of the outcome measures during and after the treatment as compared to the hypothetical control group.

after a 28-day prospective baseline period using a headache diary to record headache symptoms and any abortive medications used, subjects who meet diagnostic criteria for chronic migraine and don't meet the exclusion criteria will receive rtms for 4 weeks. the outcome measure will be evaluated at 4 weeks. during the whole trial period, any adverse events are requested to be recorded in the headache diary for analyses. the primary outcome is 50% reduction in the number of days with headache. 50% reduction as assessed by migraine days, moderate/severe headache days, the mean vrs, and conversion to episodic migraine, sgic, the change from baseline halt-28, hit-6, and msq v2.1, are used as secondary outcome measures for exploring other benefits associated with treatment.

Eligibility criteria:
inclusion criteria: * subjects meeting the diagnostic criteria for chronic migraine according to the international classification of headache disorders, 3rd edition. * the duration of chronic migraine ≥ 6 months. * age range of 18 - 65 years old exclusion criteria: * secondary headaches except moh * any change of the prophylaxis or the analgesic drug strategy during the baseline and follow-up period * structural brain lesions * seizures * severe systemic disease * tms contraindications (such as metal implants) * psychosis * severe depression or anxiety * drug or alcohol dependence * pregnancy * participating in other experiments at the same time

Keywords: transcranial magnetic stimulation migraine disorders prophylaxis treatment outcome brain
prediction of spinal anesthesia-induced hypotension in cesarian section: carotid artery-corrected flow time versus cardiometry

Conditions: Spinal Anesthesia; Hypotension; Cesarian Section; Carotid Artery; Corrected Flow Time; Cardiometry

Summary: this research aimed to evaluate and compare the role of carotid corrected flow time (ftc) and electrical cardiometry (ec) in the prediction and prevention of post-spinal hypotension in elective cesarian section.

spinal anesthesia is the procedure of choice for elective cesarean section (cs) because it avoids the most common side effects related to general anesthesia, such as the risk of aspiration, airway problems and the negative effects of intravenous anesthetic drugs on the fetus. accurate prediction of post-spinal hypotension could enhance clinical decision-making, optimize management, and facilitate early intervention. more than thirty predictors were used in the prediction of post-spinal hypotension including demographic data, hemodynamic variables, postural stress testing, peripheral perfusion indices, volume and fluid responsiveness indices, and genetic polymorphism. the baseline parameters obtained via the bioreactance-based system may serve as a predictor of post-spinal anesthesia hypotension in parturient.

Eligibility criteria:
inclusion criteria: * aged ≥ 18 years. * american society of anesthesiologists (asa) physical status ii. * gestational age (ga) ≥ 36 weeks. * women planned elective cesarean section under spinal anesthesia. exclusion criteria: * patient refusal to participate in the study. * gestational age of \< 36 or ≥40 weeks of pregnancy. * pregnancy-induced hypertension. * diabetes. * cardiovascular diseases, arrhythmia. * antepartum hemorrhage. * body mass index (bmi) above 36 kg/m2. * clinical fetal complications.
incidence of regurgitation in patients undergoing intubation in semi-fowler v/s supine position

Conditions: Inguinal Hernia Bilateral

Summary: one of the most dreaded complication of general anaesthesia is aspiration of gastric contents after induction of general anaesthesia.many endeavours and measures have been practiced to reduce the incidence of aspiration pneumonia.one such method is to intubate the patient in semi-fowler or supine posture.my study is aimed to find out safe and best position between these two after induction of general anaesthesia to prevent aspiration pneumonia.


Eligibility criteria:
inclusion criteria: * adults 18-60 years of age * must be able to talk exclusion criteria: * patients less than 18 years of age or above 60, * pregnant women * handicapped individuals * patients with intestinal obstruction
guidelines to practice: reducing asthma health disparities through guideline implementation

Conditions: Asthma

Summary: the primary hypothesis the investigators will test is that that improving asthma guideline implementation and providing patients with a unified asthma management plan using a multi-component and multilevel intervention will improve patient-centered asthma outcomes compared to health plan case management, passive guideline dissemination and provider education.

the study will use a factorial randomized controlled design to assess the comparative effectiveness of the following interventions among 8 community health centers and 550 patients with: * health plan enhanced intervention plus traditional provider education: health plans will enhance case management support, monitor medication fills, and increase passive guideline dissemination. traditional provider education will consist of implementation of the pace asthma education program. note that all participants and clinics will receive this intervention. in effect, this will be the base active comparator arm of the study. * home visit intervention: community health workers will provide in-home tailored asthma support: assess asthma self-management knowledge and skills, conduct a home environmental assessment focused on asthma triggers, and conduct follow-up visits to support patient actions to improve asthma control based on unified asthma management plan. * enhanced clinic intervention with system integration: clinics will implement a multi-component intervention that includes decision support, audit and feedback, provider and staff education, team-based care, and training and feedback in implementing office spirometry and allergy testing. ehr enhancements and clinic systems redesign will support this work. the ehr will also provide a platform for sharing a common asthma management plan and enhancing communications among care team members (clinicians, chws, plan case managers). all four intervention groups will receive enhanced health plan intervention + provider education. the four study arms will receive the following additional different interventions: (a) usual clinic care; (b) a + home visit, (c) enhanced clinic care + system integration, and (d) c + home visit.

Eligibility criteria:
inclusion criteria: * age 5-75 * provider-verified diagnosis of asthma * have uncontrolled asthma * primary language of english,spanish or vietnamese * patient of neighborcare or healthpoint health * insured by molina healthcare or community health plan of washington exclusion criteria: * patient planning to leave neighborcare or healthpoint health within the next 12 months * household appearing to be unsafe for a visit by a community health worker * co-existing medical conditions that make asthma control a low priority for patient management or that confound outcome measurement or that preclude participation in self-management * participation in another asthma research study

Keywords: asthma guidelines community health worker